(2 days)
The Hemashield Platinum vascular grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Not Found
The provided text describes a Special 510(k) submission for a device modification, not a study proving a device meets acceptance criteria through performance evaluation. The submission focuses on demonstrating substantial equivalence to a predicate device, meaning the modified device is as safe and effective as a legally marketed device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.
Here's why and what information is available:
- Focus of the Document: The core of this document is a 510(k) premarket notification. These notifications primarily aim to show that a new device is "substantially equivalent" to a predicate device already on the market. This often means demonstrating identical or very similar characteristics and performance.
- Lack of Acceptance Criteria and Performance Data: The document states that the "Hemashield Platinum grafts are different from the Hemashield Gold grafts only in the label claim for permeability." All other aspects are listed as "identical." This implies that the modification did not necessitate new performance studies against specific acceptance criteria for most features, as they are considered identical to a previously approved device.
- Summary of Substantial Equivalence: The document explicitly lists the following similarities between the modified device and the predicate device, which serve as the basis for claiming substantial equivalence rather than new performance data:
- Identical indications for use
- Identical labeling
- Identical manufacturing process flow
- Identical operating principle
- Incorporate identical materials
- Have the identical shelf-life (5 years)
- Are packaged and sterilized using identical packaging materials and processes
To directly answer your request based only on the provided text, I must state that the information is not available. The document does not describe a study with acceptance criteria and device performance in the way you've outlined.
Here's a breakdown of why each specific point you requested cannot be fulfilled by this document:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on declaring identity with a predicate device for most specifications and a specific difference in label claim for permeability, without providing quantitative performance data against laid-out acceptance criteria.
- Sample sized used for the test set and the data provenance: Not present. No specific test set or study data are detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. There is no mention of expert involvement in establishing ground truth for a test set.
- Adjudication method for the test set: Not present. No test set is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant and not present. This is a medical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant and not present. This is a vascular graft, not a software algorithm.
- The type of ground truth used: Not present, as no new performance study generating ground truth is described.
- The sample size for the training set: Not present, as no computational model requiring a training set is described.
- How the ground truth for the training set was established: Not present.
In summary, this document is a regulatory submission for a device modification based on substantial equivalence, not a performance study report.
{0}------------------------------------------------
APR 1 9 2002
Ko2/a13
Special 510(k) -- Device Modification Hemashield Platinum Woven Double Velour Vascular Grafts Hemashield Platinum Microvel Double Velour Vascular Grafts April 9, 2002
Section 5
Summary of Substantial Equivalence
| Summary ofModifications | As shown previously in this submission, the Hemashield Platinumgrafts are different from the Hemashield Gold grafts only in the labelclaim for permeability. |
|---|---|
| SubstantialEquivalence | The modified vascular grafts have the following similarities to thosewhich previously received 510(k) concurrence:• Identical indications for use• Identical labeling• Identical manufacturing process flow• Identical operating principle• Incorporate identical materials• Have the identical shelf-life (5 years)• Are packaged and sterilized using identical packaging materialsand processesIn summary, the Hemashield Platinum vascular grafts described in thissubmission are equivalent to the predicate device. |
Continued on next page
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2002
Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
K021213 Re:
Trade Name: Modification to Hemashield Platinum Woven/Microvel Double Velour Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular graft prosthesis of 6 millimeters and greater diameter. Regulatory Class: Class II (two) Product Code: MAL Dated: April 16, 2002 Received: April 17, 2002
Dear Ms. Bolton:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for two based in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , aross provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
{2}------------------------------------------------
Page 2 - Ms. Jennifer Bolton, RAC
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
hre
Donna Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Special 510(k) - Device Modification Hemashield Platinum Woven Double Velour Vascular Grafts Hemashield Platinum Microvel Double Velour Vascular Grafts April 9, 2002
Indications For Use
| 510(k)Number(if known) | Unknown |
|---|---|
| DeviceName: | Hemashield Platinum Woven Double Velour Vascular GraftsHemashield Platinum Microvel Double Velour Vascular Grafts |
| Indicationsfor Use | The Hemashield Platinum vascular grafts are indicated for use in thereplacement or repair of arteries affected with aneurysmal or occlusivedisease. The prosthesis is also recommended for use in patientsrequiring systemic heparinization prior to, or during, surgery. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use_ (Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices 510(k) Number_ Koz Z/Z-(Z-12-12-12-12-12-12-12
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”